Kornimate/medical-research-clean huggingface dataset:
effect of cross-linked hyaluronic acid filler versus botulinum toxin type a (botox) in management of gummy smile

Conditions: Gummy Smile Due to Hypermobile Upper Lip

Summary: a smile is supposed to express one's feelings and expressions, for that there has been an awakening concern for the appearance of gummy smile. gummy smile is the appearance of about 2mm or more of the gingiva during smiling. it may affect the quality of life of individuals affecting their self-esteem; patients desire to look good not only while resting but while dynamically expressing themselves too. variable factors contribute to this gingival display whether skeletal, dental or muscular. variable treatment modalities are done solely or in adjunction to each other for the treatment of gummy smile including both surgical or nonsurgical procedures.

in patients not preferring surgical correction of gummy smile, botulinum toxin injection type a can be a helpful solution for reduction of peri-oral muscular hypermobility. a characteristic feature of botulinum toxin is the need for the re-injection in short intervals of time to yield better lasting effects. the use of cross-linked hyaluronic acid dermal fillers when used to myomodulate the peri-oral muscles give more immediate results and reduces the need for re-injection at shorter intervals. botulinum toxin type a, a toxin produced by the bacteria clostridium botulinum, has been widely used in different therapeutic and cosmetic applications in dentistry. amongst its important applications is the treatment of gummy smile by reducing the hypermobility of the peri-oral muscles through chemical denervation. botox elicits temporary results and requires re-injection at certain time points. it is a safe, suitable, transient solution for patients not willing to undergo any surgical intervention to manage their gummy smile. another approach for the non invasive treatment of muscular hypermobility is the injection of cross linked hyaluronic acid filler. once the filler is injected, it typically occupies space that lessens the muscle movement limiting its hypermobility. instant smile enhancement is observed upon injection of cross-linked hyaluronic acid fillers and no need to repeat the injection at closer periods of time. hyaluronic acid fillers are non-permanent fillers that are degradable by hyaluronidase and cross linking renders them more resistant to enzymatic degradation thus lasting longer.

Eligibility criteria:
inclusion criteria: * patients with excessive gingival display ranging from 3-8mm due to hypermobile lip. * age ranges from 18 years or above. exclusion criteria: * excessive gingival display due to other etiological factors. * patients allergic to botox or hyaluronic acid fillers. * patients with any medical condition that contraindicates botox or hyaluronic acid filler injection. * patients previously injected with permanent fillers. * pregnancy. * breastfeeding females. * patients with active inflammatory or infectious disease at intended site of injection.
treatment of diffuse large b cell lymphoma

Conditions: Diffuse Large B Cell Lymphoma

Summary: the purpose of this study is to evaluate the efficacy and safety of yangzhengxiaoji capsule combination chemotherapy for iii/iv diffuse large b cell lymphoma.


Eligibility criteria:
inclusion criteria: - age range 14-70 years old; ecog performance status 0-2; estimated survival time \> 3 months histological confirmed diffuse large b cell lymphoma(iii/iv) none of chemotherapy or radiotherapy has been previously used none of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/l, platelet ≥ 100×109/l, alt and ast ≤ 2×uln, serum bilirubin ≤ 1.5×uln, serum creatine ≤ 1.5×upper limitation of normal (uln), serum albumin ≥ 30g/l at least one measurable lesion none of other serious diseases, cardiopulmonary function is normal pregnancy test of women at reproductive age must be negative patients could be followed up none of other relative treatments including the traditional chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments. exclusion criteria: * disagreement on blood sample collection patients allergic of any of drug in this regimen or with metabolic disorder pregnant or lactating women serious medical illness likely to interfere with participation serious infection primitive or secondary tumors of central nervous system chemotherapy or radiotherapy contraindication the evidence of cns metastasis history of peripheral nervous disorder or dysphrenia patients participating in other clinical trials patients taking other antitumor drugs patients estimated to be unsuitable by investigation
treatment of erectile dysfunction ii

Conditions: Erectile Dysfunction

Summary: randomized, placebo-controlled, double-blind, parallel design, phase 3 study to evaluate the safety and efficacy of udenafil, an orally administered, potent and selective inhibitor of pde-5 versus placebo for the treatment of subjects with erectile dysfunction (ed).

multi-center, randomized, double-blind, placebo-controlled, parallel-group design, phase 3 pivotal study to investigate the efficacay and safety of 50 mg, 100 mg and 150 mg udenafil tablets compared with placebo in men with ed. this study consisted of a 4-week, treatment free run-in period followed by a treatment period of 12 weeks, with an on-demand dosing regimen.

Eligibility criteria:
inclusion criteria: * male, at least 19 years of age * stable monogamous relationship for at least 6 months with a consenting female partner who is at least 19 years of age, vaginal intercourse is a required study activity * history of ed (clinically defined as the inability to attain and maintain an erection of the penis sufficient to permit satisfactory sexual intercourse) of at least 3 months duration * partner is not pregnant or lactating exclusion criteria: * history of new-onset symptomatic coronary artery disease within the last 3 months or a history of myocardial infarction or cardiac surgical procedure within six months * cardiac arrhythmias requiring antiarrhythmic treatment * symptomatic congestive heart failure * taking nitrate medication in any form * uncontrolled diabetes (hba1c ≥ 13%) * hypersensitivity to phosphodiesterase type 5 (pde-5) inhibitors such as viagra®, cialis® or levitra® * previously failed to respond to pde-5 inhibitors such as viagra®, cialis® or levitra®
a 5-year longitudinal observational study of patients undergoing therapy for inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases; Crohn's Disease; Ulcerative Colitis; Indeterminate Colitis

Summary: target-ibd is a 5-year, longitudinal, observational study of adult and pediatric patients (age 2 and above) being managed for inflammatory bowel disease (ibd) in usual clinical practice. target-ibd will create a research registry of patients with ibd within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.


Eligibility criteria:
inclusion criteria: 1. adults and children (age 2 or older) with a diagnosis of crohn's disease (cd), ulcerative colitis (uc), or indeterminate colitis (ibdu) having been prescribed any ibd treatment (initial or subsequent) outside of a clinical trial. 2. have plans for future visits at the site for continued management of ibd. exclusion criteria: 1. inability to provide written informed consent/assent. 2. being enrolled in any interventional study or trial for ibd treatment. note: patient may be enrolled in other registries or studies where ibd treatment outcomes are observed and/or reported (such as center-based registries). 3. prior total abdominal colectomy for uc or ibdu.

Keywords: crohn's disease ulcerative colitis indeterminate colitis digestive system diseases
isavuconazole (bal8557) in the treatment of candidemia and other invasive candida infections

Conditions: Candidiasis, Invasive; Candidemia; Mycoses

Summary: the purpose of the study is to compare the safety and efficacy of isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive candida infections.

candida infections, representing approximately 80% of all major systemic fungal infections, are the fourth most common cause of nosocomial bloodstream infections, with a mortality rate of 40%. isavuconazole is not yet approved for the treatment of fungal infections. this study investigates the efficacy and safety of intravenous and oral isavuconazole. patients are randomized to isavuconazole and the reference regimen. patients with a positive blood- or deep tissue culture of candida fungi can be included.

Eligibility criteria:
inclusion criteria: * patients with candidemia or with an invasive candida infection * presence of fever, hypothermia or other appropriate local sign of infection * female patients must be non-lactating and at no risk of pregnancy exclusion criteria: * patients with a sole diagnosis of mucocutaneous candidiasis, i.e. oropharyngeal, esophageal or genital candidiasis; or candidal lower urinary tract infection or candida isolated solely from respiratory tract specimens * patients with candidemia who failed a previous antifungal therapy for the same infection * patients previously enrolled in a phase iii study with isavuconazole * patients with a body weight \<40kg

Keywords: invasive candida infections bal8557 asp9766 isavuconazole candidemia candidemia and other invasive candida infections phase iii study
study of dhp1401 in patients with mild-moderate alzheimer's disease treated with donepezil(drama)

Conditions: Mild-moderate Alzheimer's Disease

Summary: the objective of this study is to evaluate the efficacy and safety of dhp1401 in patients with mild-moderate alzheimer's disease treated with donepezil


Eligibility criteria:
inclusion criteria: 1. ≥55 and ≤85 years of age 2. patient who was diagnosed mild to moderate alzheimer's disease by national institute of neurological and communicative disorders and stroke-alzheimer's disease and related disorders association(nincds-adrda) or national institute on aging-alzheimer's association(niaaa) 3. korean mini-mental state examination(k-mmse) score 15 to 26 4. patient who maintained on donepezil without dose escalation or reduction for at least during 3 months before screening (visit 1) 5. clinical dementia rating(cdr) score 0.5 to 2.0 at screening (visit 1) 6. written informed consent voluntarily 7. patient who has a relative/caregiver who support the information of patient's status 8. patient who are deemed adequate to participate in the clinical trial by the investigator 9. infertility or patients and his/her spouse consent with contraception during the study period exclusion criteria: 1. a diagnosis of vascular dementia or dementia by other cause according to the criteria of the nincds-adrda 2. structural brain abnormality or impairment 3. schizophrenia, depressive disorder and bipolar disorder 4. any neurological disease except alzheimer' disease (ex. parkinson's disease, huntington's disease, brain tumor, normal-pressure hydrocephalus, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, epilepsy, delusion and head injury required hospitalization) 5. history of any cancer within previous 5 years 6. history of stroke within previous 2 years 7. heart failure required medication or interventional treatment including myocardial infarction, valvular heart disease, arrhythmia within previous 1 year 8. uncontrollable diabetes 9. uncontrollable hypertension 10. abnormal liver or kidney function 11. patient with significant clinical meaning to affect cognitive function 12. patient who participated in other clinical trial within previous 3 months or has a plan to participate in other clinical trial during study period 13. history of abuse of a drug or alcohol within previous 2 years 14. patient who has administrated other acetylcholinesterase inhibitors except donepezil within previous 4 weeks 15. patient who are deemed inadequate to participate in the clinical trial by the investigator(ex. a illiteracy, etc.) 16. history of hypersensitivity reaction to the main ingredient of the investigational drugs 17. patient who has administrated other drugs except donepezil for dementia treatment (it is possible to enroll after washout for 28 days)

Keywords: alzheimer's disease
drug concentration analysis of micafungin in overweight, obese, and extremely obese volunteers

Conditions: Obesity; Nutrition Disorders; Overweight

Summary: the purpose of this study is to assess the drug concentration of micafungin amongst healthy volunteers having different weight groups.

this is a single center study. a total of 36 adult volunteers will be consented for the study. volunteers will be admitted for an overnight stay. half will be female and half male. twelve volunteers will have a body mass index (bmi) less than 25 kg/m2, 12 will have a bmi 25-40 kg/m2, and 12 will have a bmi greater than 40 kg/m2. volunteers will have height and weight measured after they have consented to participate. exactly half the volunteers in each category will received a single dose of intravenous micafungin of 100 mg, while the other half will receive 300 mg as determined by a coin flip. the volunteers will have blood drawn via an intravenous catheter just prior to the dose, and then at 1, 4, 8, 12, 16, and 24h after the drug dose. the intravenous catheter is then removed after the 24h blood draw, and the volunteer discharged from the study. compensation will be provided to the participants for their time.

Eligibility criteria:
inclusion criteria: * male and female subjects * 18 years or older * all racial and ethnic origins * english or spanish speaking exclusion criteria: * pregnant or nursing or unwilling to use a reliable contraception method during the study. the effects of micafungin on pregnancy are unknown. in addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of micafungin, so that the pregnancy and post-partum state would be a confounding variable. * abnormal liver function tests: transaminases\>10 times upper limit of normal, alkaline phosphatase\>5 times upper limit of normal, total bilirubin\>5 times upper limit of normal. * creatinine clearance \< 70 ml/min as estimated by the cockcroft-gault equation * history of allergies to echinocandins * echinocandins are contraindicated for any reason * volunteers unwilling to comply with study procedures. * suspected or documented systemic fungal infection.

Keywords: micafungin body weight anti-infective agents signs and symptoms mycoses therapeutic uses antifungal agents overnutrition pharmacologic actions
evaluation of self-ligating brackets plus minor surgery in treating crowded cases of malocclusion

Conditions: Malocclusion of Anterior Teeth

Summary: patients at the orthodontic department of university of damascus dental school will be examined and subjects who meet the inclusion criteria will be admitted then the initial diagnostic records (diagnostic gypsum samples - internal and external oral photographs as well as radiographic images) will be studied to ensure that the selection criteria are accurately matched. the aim of this study is to compare three groups of patients with severe crowding of the upper anterior teeth: * group 1 : patients will be treated using self-ligating brackets * group 2 : patients will be treated using self-ligating brackets associated with flapless corticotomy. * group 3 : patients will be treated using traditional brackets (i.e. brackets positioned on the labial surface of the teeth) at the end of leveling and aligning phase, we will compare the self-ligating brackets and traditional brackets ( the acceleration of teeth movement, dental and alveolar changes and other variables ) also, there is an intention to study the effectiveness of using flapless corticotomy with the self-ligating brackets.

the sample of this study will be chosen according the following steps: * the examination of patients referred to the department of orthodontics at the university of damascus dental school (clinical examination, diagnostic plaster models, radiographic photos , external and internal oral photographs) then subjects who meet the inclusion criteria will be included in this trial. * a random sample of 100 patients from the sampling frame will be chosen. * an information sheet ( including the research objective and treatment plan in detail ) will be given to each candidate. then consent forms will be collected from those who agree to participate. * a random selection of 60 patients will be performed. then a random distribution of these patients to 3 groups will be done.

Eligibility criteria:
inclusion criteria: 1. age of patients: 17-28 years. 2. severe crowding greater than 6 mm on the upper jaw in which orthodontic treatment requires at least two upper extraction. 3. the little's index of irregularity is over 7 mm. 4. there is no previous orthodontic treatment. 5. the patient dose not take any drug may interfere with the tooth movement (cortisone, nsaids, ...). 6. the patient has good oral health (i.e., plaque index is less or equal to 1 according to loe and silness (1963). 7. class i or mild class ii (anb ≤ 5) or mild class iii (anb ≥ 0) skeletal relationship. 8. overbite is between 0-4 mm. 9. there is no skeletal constriction on the upper jaw. 10. full presence of all permanent teeth in the dental arch (except for third molars) exclusion criteria: 1. any systemic diseases that would affect tooth movement . 2. any congenital syndromes or cleft lip and palate cases 3. bad oral health
an open-label study of oral nnz-2591 in phelan-mcdermid syndrome (pms-001)

Conditions: Phelan-McDermid Syndrome

Summary: a study of the safety, tolerability and pharmacokinetics of nnz-2591 and measures of efficacy in children and adolescents with phelan-mcdermid syndrome.

the primary purpose of this study is to investigate the safety, tolerability and pharmacokinetics of treatment with nnz-2591 oral solution in children and adolescents with phelan-mcdermid syndrome. the secondary purpose is to investigate measures of efficacy. subjects will receive treatment with nnz-2591 oral solution (50 mg/ml) doses for a total of 13 weeks.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of pms with a documented disease-causing genetic abnormality of shank3. 2. males or females aged 3-12 years. 3. body weight of 12 kg or higher at screening. 4. subjects with a clinical global impression - severity (cgi-s) score of 4 or greater at the screening visit. 5. not actively undergoing regression or loss of skills, defined as no persistent loss of previously acquired developmental skills for a period within 3 months of the screening visit 6. each subject must be able to swallow the study medication provided as a liquid solution. 7. caregiver(s) must have sufficient english language skills. exclusion criteria: 1. body weight \< 12kg at screening 2. clinically significant abnormalities in safety laboratory tests and vital signs at screening. 3. abnormal qtcf interval or prolongation at screening. 4. any other clinically significant finding on ecg at the screening visit. 5. positive for severe acute respiratory syndrome coronavirus 2 (sarscov- 2) and previous covid 19 infection with last 12 months that required hospitalization 6. unstable or changes psychotropic treatment 2 weeks prior to screening . 7. excluded concomitant treatments. 8. actively undergoing regression or loss of skills. 9. unstable seizure profile. 10. current clinically significant renal conditions and abnormalities 11. current clinically significant cardiovascular, renal, hepatic, gastrointestinal, respiratory, endocrine disease, or clinically significant organ impairment. 12. current clinically significant hypo or hyperthyroidism, type 1 or type 2 diabetes mellitus requiring insulin (whether well controlled or uncontrolled), or uncontrolled type 1 or type 2 diabetes. 13. has planned surgery during the study. 14. history of, or current, cerebrovascular disease or brain trauma. 15. history of, or current catatonia or catatonia-like symptoms. 16. history of, or current, malignancy. 17. current major or persistent depressive disorder (including bipolar depression). 18. significant, uncorrected visual or uncorrected hearing impairment. 19. allergy to strawberry. 20. positive pregnancy test 21. subject is judged by the investigator or medical monitor to be inappropriate for the study

Keywords: phelan-mcdermid syndrome
a post-marketing surveillance study on erbitux in combination with platinum-based chemotherapy in metastatic/recurrent squamous cell cancer of the head and neck

Conditions: Neoplasms, Squamous Cell

Summary: this is a prospective post-marketing surveillance (pms) study to collect safety information from more than 600 subjects with recurrent and/or metastatic squamous cell cancer of the head and neck (scchn) treated with erbitux as final evaluable cases. this pms study is requested by the korean regulatory authorities. after approval of new indication in korea, there is a requirement to investigate more than 600 subjects during six years, to continue monitoring and provide further information about safety and toxicity in clinical practice.

the pms study is planned to be conducted within 6 years from the approval date of the new indication in approximately 50 institutions in korea. objectives primary objective: * to obtain safety information on the use of erbitux in subjects with recurrent and/or metastatic scchn in terms of frequency and severity of adverse events (aes) secondary objectives: * to gather clinical efficacy information of the treatment during the pms period, each subject's background, subject's medical history (surgery, anti-cancer treatment), erbitux treatment status, concurrent medication, response evaluation, status and reason of discontinuation, all aes (regardless of the causal relationship to erbitux), and abnormal results of laboratory tests will be collected. the pms will be based on all cases treated with erbitux at least once. erbitux will be prescribed to recurrent and/or metastatic scchn subjects according to the approved national label as in routine clinical practice under the supervision of an investigator experienced in the use of antineoplastic medicinal products. prior to the first infusion, subjects will receive pre-medication with an antihistamine and a corticosteroid. the initial dose of erbitux is 400 mg/m2 body surface area and the subsequent weekly doses are 250 mg/m2 each administered intravenously via in-line filtration with an infusion pump, gravity drip, or a syringe pump. the recommended infusion period for the initial dose is 120 minutes and for the subsequent weekly doses is 60 minutes with the maximum infusion rate not exceeding 10 mg/min, equivalent to 5 ml/min of erbitux 2 mg/ml or 2ml/min of erbitux 5mg/ml.

Eligibility criteria:
inclusion criteria: * subjects who are eligible for erbitux treatment according to the indication in the national label of erbitux. the national label approved by korea food \& drug administration is "erbitux in combination with radiation therapy is indicated for the treatment of subjects with metastatic/recurrent scchn.

Keywords: head and neck neoplasms carcinoma, squamous cell cetuximab